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Senior Design Quality Assurance Engineer, Design Control and Risk Management Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Maple Grove, MN, US, 55311

Additional Location(s): Ireland-Galway

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role:
The Design Assurance Senior Engineer is a quality engineer who supports medical device product development from concept through commercialization.  Design Assurance engineers work with high-performance cross-functional team members to establish and maintain the design control deliverables, risk management activities, and DHF compliance within Interventional Cardiology to ensure delivery of the highest quality product to the customer.  Specifically, this engineer will support our Compliance and Continuous Improvement (CCI) team and will support and improve the quality systems and practices used by our teams rather than execute design control activities for a product. This engineer facilitates, implements, and drives continuous improvement initiatives in the areas of Design Controls, Risk Management, and Post Market Surveillance. 

Your responsibilities include:

  • Actively promotes and participates in a cross-functional and cross-divisional environment.
  • Demonstrates expert knowledge and application of Design Control, Risk Management, and Post-Market Surveillance. 
  • Coaches and mentors cross-functional team members in the application of the Design Control, Risk Management, and Post-Market Surveillance requirements to their products through formal classroom training, wiki content, functional meetings, and team and individual consulting. 
  • Develops divisional implementation strategy for changes within the quality system, including developing training, communication, change management strategy, & self-serve guidance for teams to execute the strategy; documenting plans, ensuring plan completion, & securing support of key stakeholders for the change. 
  • Engages to represent the division on various global and multi-divisional quality system improvement projects by proactively soliciting input from IC teams, reviewing proposals to assess impact on IC, and advocating for IC needs amongst global counterparts. Champions change, and as applicable, owns quality system NCEPs, CAPAs, and project plans relating to Design Control and Risk Management.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Successfully navigates in grey spaces and provides logical and creative guidance to teams. 
  • Demonstrates good working knowledge and application of regulatory requirements and internal expectations.
  • Monitors regulatory submission & audit questions and responses, proactively communicates lessons learned to internal customers, and assists teams with response writing for quality system-related questions. 
  • Works with internal customers who represent related and interconnected processes such as Management Review, Design Controls, Risk Management, Cybersecurity, Production and Process Control, Clinical, Medical Safety, Regulatory, and Complaint handling.   

What we’re looking for in you:
Minimum qualifications:

  • Bachelor’s degree in an Engineering discipline or related STEM field of study
  • A minimum of 5 years of experience in related medical device experience, at least three years of which must include experience in design assurance, design control, or risk management
  • Self-motivated with a passion for solving problems and a bias for action
  • Hands-on approach to product development
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies
  • ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

Preferred qualifications:

  • 6+ years of experience in design assurance, new product development, risk management, or product lifecycle management 
  • Previous development of complex medical device system experience
  • Previous experience with developing capital equipment as a medical device
  • Experience working with cross-functional groups such as Regulatory, Research & Development, Clinical, Quality, Operations, and Complaints Handling 

#LI-Hybrid

 

Requisition ID: 529896

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.


Nearest Major Market: Minneapolis

Job Segment: Controls Engineer, Risk Management, Medical, Quality Engineer, Manager, Engineering, Finance, Healthcare, Management

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